FDA Inspection
TMC Acquisitions LLCTMC Acquisitions LLC – FDA Inspection, Oct 24, 2018
Record Details
This FDA Inspection record concerns TMC Acquisitions LLC, with an inspection on October 24, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 56107a0d-bf46-459a-8d66-ee15efb61e5b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1069619
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
12- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.84(d)(1)Component identity verification
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.125(b)Examination of issued labels
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
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